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The Policy VaultThe Policy Vault

IsturisaBlue Cross Blue Shield of Oklahoma

Cushing’s syndrome

Initial criteria

  • Diagnosis of Cushing’s syndrome AND ONE of the following: (a) Inadequate response to surgery OR (b) Not a candidate for surgery AND persistent or recurrent disease evidenced by mean of three 24-hour urine free cortisol >1.3× upper limit of normal OR morning plasma ACTH above lower limit of normal
  • Prescriber is a specialist in the area of the diagnosis (e.g., endocrinologist) or has consulted with a specialist
  • Patient will NOT be using requested agent in combination with glucocorticoid replacement therapy
  • Patient does NOT have any FDA labeled contraindications to the requested agent
  • ONE of the following: (a) The patient is currently being treated with the requested agent and stable OR (b) Request is for specified BCBS IL Fully Insured, ASO, HIM or Non-ERISA municipal plan OR (c) Patient has tried and had inadequate response to ≥1 of following [with documentation]: mifepristone, Signifor/Signifor LAR (pasireotide), Recorlev (levoketoconazole), cabergoline, metyrapone, Lysodren (mitotane) OR (d) One of those agents was discontinued due to lack of efficacy/adverse event OR (e) Intolerance or hypersensitivity to mifepristone, pasireotide, or levoketoconazole OR (f) FDA labeled contraindication to mifepristone, pasireotide, and levoketoconazole OR (g) Agent expected ineffective / poor adherence / worsen comorbidity / adverse reaction / not in best interest based on medical necessity OR (h) Tried another drug in same pharmacologic class discontinued due to efficacy/adverse event
  • AND ONE of the following: (a) Request from specified BCBS IL plan OR (b) Tried and had inadequate response to ketoconazole tablets OR (c) Ketoconazole discontinued due to lack of efficacy/adverse event OR (d) Intolerance or hypersensitivity OR (e) FDA labeled contraindication OR (f) Expected to be ineffective / adherence barrier / worsen comorbidity / cause adverse event / not in best interest OR (g) Tried another in same pharmacologic class discontinued due to efficacy/adverse event
  • Patient age is within or supported for FDA labeling for the requested indication
  • Alternate pathway (Ohio specific): member resides in Ohio AND plan is Fully Insured or HIM Shop AND no contraindications AND one of the following: (a) another FDA labeled indication OR (b) compendia-supported indication OR (c) prescriber submitted 2 peer-reviewed journal articles supporting proposed use (case studies not acceptable)

Reauthorization criteria

  • Patient previously approved for requested agent through plan’s Prior Authorization process
  • Patient has had clinical benefit with the requested agent
  • Prescriber is a specialist in the area of diagnosis (e.g., endocrinologist) or has consulted with a specialist
  • Patient will NOT be using the requested agent in combination with glucocorticoid replacement therapy
  • Patient does NOT have any FDA labeled contraindications

Approval duration

BCBSOK: 36 months; BCBSIL/BCBSMT: 12 months; others: 6 months; Renewal BCBSOK: 36 months; others: 12 months